Amneal Scores FDA Approval of Alymsys®, a Biosimilar of Bevacizumab

On March 1, Amneal announced that it had entered the biosimilar market with the FDA approval of its filgrastim biosimilar (Releuko®). On April 14, the company announced another major step on its biosimilar journey: the approval of its second biosimilar, a new version of bevacizumab.

Dubbed Alymsys (bevacizumab-maly), the new agent is the third Avastin® biosimilar approved in the US. The biosimilar was developed by mAbxience, it will be marketed in the US by Amneal.

Alymsys is approved for the treatment of:

  • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy (first- or second-line treatment)
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy (second-line treatment for patients who have progressed on a first-line bevacizumab-containing regimen)
  • Non-squamous non–small cell lung cancer, in combination with carboplatin and paclitaxel (as first-line therapy)
  • Recurrent glioblastoma in adults
  • Metastatic renal cell carcinoma, in combination with interferon alfa
  • Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan
  • Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel

Amneal is awaiting word on its third biosimilar entry, a pegfilgrastim, which is presently awaiting FDA approval. No word is presently available on the launch date for Alymsys.

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